Article excerpt

ROCKVILLE, MD.--A standardized approach to collecting data in people from different ethnic and racial groups in new drug trials has been recommended by the Food and Drug Administration.

The proposal reflects the increased awareness that responses to drugs are not always uniform across the population.

The FDA's draft "Guidance for Industry" document provides recommendations on different categories of ethnic and racial demographic groups to use when collecting effectiveness and safety data in clinical trials. Using standardized categories when collecting such data "will enhance the early identification of differences in response among racial and ethnic groups during the evaluation of safety and effectiveness of FDA-regulated products," the FDA said in a statement. Examples of such differences that have already been observed in trials include the finding that hypertensive black patients do not respond as well to [beta]-blockers or angiotensin-converting enzyme inhibitors. Black patients with hepatitic C also have not responded as well to treatment with interferon-a, compared with other racial groups in clinical trials.

Other differences cited by the FDA include racial differences in skin structure and physiology that have been found to affect response to dermatologic and topically applied products. …